IBMA input and EFSA/PSC response at industry meeting April 2012
Progress of peer reviews and EFSA conclusions for List-4 biocontrol substances? Information about the on-going review programme. In this context, an up-to-date summary time table would be welcome. EFSA were able to present a up to date summary timetable
IBMA propose initiation of a lessons learned document after the conclusion of the List-4 EFSA assessment by the end of 2012, in Q1 2013. EFSA acknowledged value in a Lessons Learned document but it is early to provide a timetable. It intends to put it to the next PSC meeting in October. Are there new guidance documents for micro- organisms and other active substances in preparation? EFSA acknowledge the need for these documents and will consider their development. Which and how fully have OECD GD’s been used for list 4 reviews? EFSA advised GDs for MBCAs have not been referred to.
EFSA approach to mixtures of compounds like plant extracts? Attitude to concept for characterisation of mixtures & to lead substance concept for RA? Have consequences been considered for natural substances if radio labelling is obligatory?EFSA advised that there is another forum in particular an expert group addressing these specific issues.
What are we waiting for? EFSA advised the completed commenting table from RMS will be presented by 30th April and the opinion will be delivered to EU COM in Q4 2012 EFSA opinion on DAR requests and Peer Review Comments (ie. point 7 list of studies to be generated) When is it available? Is all data requested relevant? Will EFSA request additional data? How and when will any requested data be integrated? How can the additional data be provided? Relevance of SANCO/10328/2004 rev. 8 on new data evaluation? EFSA and EU COM advised it is part of EU COM risk management. MS will have to consider whether data gaps are relevant for the proposed uses. The IBMA SCLP Task Force wish to be involved at the earliest possible stage. This was not addressed
Product registration applications blocked in Member States waiting for EFSA opinion and subsequent EU Com decision. EFSA advised this is an MS issue
Studies for which no scientific or risk assessment justification exist could be either waived or extrapolated according to the OECD no. 12 guidance page 20. The SCLP Task Force supports the grouping of physical and chemical property data in the three coherent groups: SCLP acetates, SCLP alcohols and SCLP aldehydes, to be used for extrapolation to all the single active substances in each group. The ranges of melting points, boiling points, partition coefficients and flash points are predictable for each coherent group. EFSA advised review will recognise gaps but noted IBMA comments on waiving possibilities
IBMA raised the issue of batch analysis anomalies for SCLPs EFSA advised they have noted IBMA SCLP view and will refer to experts
Consequences of delayed peer reviews and EFSA conclusions on PPP authorization. Step 2 compliance post Annex I inclusion: dRR submission for many BcA deadline the 30th of April. EFSA acknowledge the consequences for MBCA producers EFSA conclusion consequence on ZRMS evaluation: MS position on National authorization? It will be addressed at MS level
List 4 active substance benefiting from Green Track inclusion Subject to delayed peer review & EFSA conclusion Consequence 1 no confirmed end points Consequence 2 possible data gaps Consequence 3 Step2 dossier based on provisional end points and data requests How will MS handle this?
List 4 MCBA Green Track included in Annex1 Application for MR submitted prior to June 14th 2011 in several MS Some MS granted authorisation under MR 1 MS suspended the procedure for assessment awaiting clarification at EU levelThe issues of the 2 cases were acknowledged
specificity of methods to determine microbial strains, validation of contaminant quantification methods validation of bioassaysIBMA ask how/when to provide information?EFSA agreed a need to develop GDs and stated it is a risk manager issue
What is the current EFSA expectation,approach and experience?EFSA strictly apply the datarequirements. Waivers may be appliedif scientifically justification is adequate.EU COM are awaiting outcome of EFSAprocurement on literature review ofMBCAs.A MBCA workshop planned by SE andsupported by DK will be organised forJune 2013.